Agomelatine is indicated for use in the treatment of major depressive episodes in adults. Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist. Binding studies indicate that agomelatine has no effect on monoamine uptake and no affinity for α, β adrenergic, histaminergic, cholinergic, dopaminergic, and benzodiazepine receptors. Agomelatine increases noradrenaline and dopamine release, specifically in the frontal cortex, and has no influence on the extracellular levels of serotonin. Agomelatine has also been shown to resynchronize circadian rhythms in animal models of circadian rhythm disruption.

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• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
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• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA’s Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

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